Measuring Quality of Life of Versacryl Relined Dentures

Comparative Study of Silicone-based Soft Liner Versus Versacryl Liner for Mandibular Complete Denture Cases(Randomized Clinical Trial)

Resilient liners were introduced in the1950s and have been used since then as a gold standard material to increase the tolerance, retention and comfort of complete dentures. Due to drawbacks of conventional resilient liners, their longevity is questionable and they require replacement which is time consuming and costly for the dentist and patient respectively. Versacryl is a biocompatible intraoral thermo-elastic material. So versatile, it can be used to improve esthetics, retention and comfort for the patient. It softens with heat and when it is inserted to patient's mouth, it cools to body temperature providing desired rigidity. This process can be repeated many times to ensuring the comfort for the patient. Versacryl has a reported predictable long term performance, durable bonding to acrylic denture bases, high fatigue endurance, excellent wear characteristics and solvent resistance with almost no free monomer in the processed material .

The investigators' trial is done in order to improve the longevity and oral health related quality of life of soft liners in comparison to silicone-based soft liners.

Study Overview

• Status: Unknown
• Conditions: Denture Liners
• Intervention / Treatment: Other: Versacryl soft liner; Other: Silicone-based soft liner

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Completely edentulous patients wearing complete dentures.
2. Flat mandibular residual ridge.
3. Mandibular denture indicated for relining.
4. Patients with minimum of 2 years and maximum of 5 years complete denture usage.
5. Angle's class I maxillary-mandibular relationship

Exclusion Criteria:

1. Drug or alcohol abuse.
2. Inflammatory changes in the oral cavity.
3. Candidiasis.
4. Any intra-oral soft tissue hyperplasia.
5. Physical reasons that could affect follow-up.
6. Psychiatric problems.
7. Heavy smokers.
8. Dentures indicated for remake.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Versacyl soft liner; Versacryl soft liner are flexible biocompatible materials with a reported predictable long term performance, durable bonding to acrylic denture bases, high fatigue endurance, excellent wear characteristics and solvent resistance with almost no free monomer in the processed material	Other: Versacryl soft liner; Versacryl has been used to construct different parts of complete and partial dentures . It can be used as thermo-elastic liner which consistency can be controlled to tailor the reline to each individual case, by adding or subtracting drops of liquid B, as explained in the directions for use. The reline can be re-adapted repeatedly, even by the patient if necessary.
Active Comparator: Silicone-based soft liner; Resilient liners were introduced in the1950s and have been used since then as a gold standard material to increase the tolerance, retention and comfort of complete dentures. Resilient liners also known as 'soft liners' can be classified as temporary or permanent, cold-cured or heat-cured.Resilient liners can be divided into two main types: plasticized acrylic resins and silicone elastomers.	Other: Silicone-based soft liner; gold standard for denture relining material

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oral health related quality of life	OHIP-49 questionnaire	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tissue keratinization	tissue keratinization index	4 months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Krunic N, Kostic M, Petrovic M, Igic M. Oral health-related quality of life of edentulous patients after complete dentures relining. Vojnosanit Pregl. 2015 Apr;72(4):307-11. doi: 10.2298/vsp1504307k.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: October 21, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Actual): October 25, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: versacryl_soft liners

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No